Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus - Full Text View

Sponsor:	Qingdao University
Information provided by:	Qingdao University
ClinicalTrials.gov Identifier:	NCT01219465

Purpose

The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.

Condition	Intervention	Phase
Diabetes Mellitus Diabetes Mellitus, Type 1 Mesenchymal Stem Cells Umbilical Cord	Biological: umbilical cord mesenchymal stem cells	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1

U.S. FDA Resources

Further study details as provided by Qingdao University:

Primary Outcome Measures:

C peptide release test [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Exogenous insulin dose [ Time Frame: 3 months ] [ Designated as safety issue: No ]
blood glucose [ Time Frame: 3 months ] [ Designated as safety issue: No ]
glycosylated Hemoglobin A1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Number of severe and documented hypoglycemic events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Immunologic reconstitution parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: umbilical cord mesenchymal stem cells Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells	Biological: umbilical cord mesenchymal stem cells Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously. Other Name: mesenchymal stem cells

Detailed Description:

Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.

Eligibility

Ages Eligible for Study:	3 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks.
Ability to provide written informed consent from patients or Child guardian.

Exclusion Criteria:

diabetic ketoacidosis.
evidence of retinopathy at baseline.
Body Mass Index >30.
Severe or acute organ damage.
Infectious diseases, e.g. HIV infection, or hepatitis B or C infection.
Severe psychiatric disorder.
Presence of malignancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219465

Locations

China, Shandong
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, China, 266003

Sponsors and Collaborators

Qingdao University

Investigators

Study Director:

Yangang Wang, MD Phd

The Affiliated Hospital of Medical College of Qingdao University

More Information

No publications provided

Responsible Party:	Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University
ClinicalTrials.gov Identifier:	NCT01219465 History of Changes
Other Study ID Numbers:	MSCT1DM003
Study First Received:	October 12, 2010
Last Updated:	October 12, 2010
Health Authority:	China: Ministry of Health

Keywords provided by Qingdao University:

Diabetes Mellitus
Diabetes Mellitus, Type 1
mesenchymal stem cells
Umbilical cord

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2012